Development and validation of a liquid chromatographic method for the simultaneous estimation of Moxifloxacin and Keterolac in opthalmic dosage form

A novel RP-HPLC method has been developed and validated for the estimation of Moxifloxacin Hydrochloride and Ketorolac Tromethamine in opthalmic dosage form. The elution followed an isocratic mode in an INERTSIL ODS column (250*4.6mm), with mobile phase KH2PO4 buffer (pH 3.5): Methanol: Acetonitrile in the ratio of 40:40:20 at a flow rate of 1.0ml / min and the effluents were monitored at 306 nm. The retention times for Moxifloxacin and Keterolac Tromethamine were found to be 2.440 and 5.503 respectively. The proposed method was validated for system suitability, linearity, precision, accuracy specificity, robustness, LOD and LOQ as per ICH guidelines. The method was found linear within the range of 60-140 µg/ml for Moxifloxacin and 48-112 µg/ml for Keterolac Tromethamine with correlation coefficient 0.999 and 0.998 respectively. Percentage recoveries of Ketorolac and Moxifloxacin were found to be in the range of 99.83% - 99.91% and 99.74% - 99.65% respectively. The LOD and LOQ of Ketorolac and Moxifloxacin were 1.73 µg/ml & 5.25 µg/ml and 1.63 µg/ml, 4.96 µg/ml respectively. Proposed method can be successfully applied for the quantitative determination of Ketorolac and Moxifloxacin in Bulk drug and Pharmaceutical dosage form.

Author(s): P. Laksmi, P. Sunil Kumar Chaitanya, K. Deepthi Reddy and Jomol Joseph

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